A Phase II Study of Metformin Plus Modified FOLFOX 6 in Patients With Metastatic Pancreatic Cancer
I. To determine if metformin (metformin hydrochloride) when added to FOLFOX ( leucovorin
calcium, fluorouracil, oxaliplatin) improves overall survival in patients with metastatic
I. To assess response rate (RR). II. To assess progression free survival (PFS). III. To
assess toxicity in patients with metastatic pancreatic cancer receiving FOLFOX and
metformin. IV. To identify tumor/serum correlative markers.
OUTLINE: Patients receive metformin hydrochloride orally (PO) twice daily (BID) on days 1-7
for an introductory period before the addition of FOLFOX. After the introductory period,
patients will continue metformin twice daily and FOLFOX therapy comprising leucovorin
calcium intravenously (IV) over 120 minutes, fluorouracil IV continuously over 46 hours, and
oxaliplatin IV over 120 minutes on day 1. Courses repeat every 14 days in the absence of
disease progression or unacceptable toxicity. After completion of study treatment,
patients are followed up for periodically.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median overall survival (OS)
Calculated using Kaplan Meier methods and the median will be estimated assuming an exponential distribution.
Time from first day of treatment to death from any cause, assessed up to 1 year
Smitha Krishnamurthi, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|